MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	460990471
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to monitoring kit w/safeset ii¿, 03 ml flush device & marvelous valve that experienced leakage.The reporter stated that " a-line tubing faulty, blood spewing from small hole on side port of stop-cock.A-line removed from patient and sequestered.The event date was on 22-oct-2024.There was patient involvement and no adverse event.The amount of blood loss was unknown.Then the customer was asked about the status of the product at the time of event she answered "when connected to tubing, with blood coming out".
Additional Manufacturer Narrative
Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of leak was confirmed on the returned set.During visual inspection, a crack was observed on the female luer of the parting line.When the returned set was primed and pressure leak tested, a leak was observed from the crack on the female luer.The probable cause of the crack is unknown.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20767006
• Report Number: 9617594-2024-01673
• Device Sequence Number: 15769004
• Product Code: DRS
• UDI-Device Identifier: 00840619069087
• UDI-Public: 00840619069087
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 460990471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown